5/7/2026

speaker
Operator
Conference Operator

Good morning. Welcome to Lanthea's first quarter 2026 conference call. All lines have been placed on mute. This call is being recorded and replay will be available in the investor section of the company's website approximately two hours after the completion of the call and will be archived for at least 30 days. I'll now turn the call over to Mark Canarney, Vice President of Investor Relations. Mark.

speaker
Mark Canarney
Vice President of Investor Relations

Thank you. Good morning. With me today are Mary Ann Haino, our CEO and Executive Chairperson, Amanda Morgan, our Chief Commercial Officer, and Bob Marshall, our CFO. We will begin with prepared remarks and then take your questions. This morning we issued a press release which was furnished to the SEC under Form 8K reporting our first quarter 2026 results. The release and today's slide presentation are available in the Investors section of our website. Any comments could include forward-looking statements, Actual results may differ materially from these statements due to a variety of risks and uncertainties, which are detailed in our SEC filings. Discussions will also include certain non-GAAP financial measures. Reconciliation of these measures to the most directly comparable GAAP financial measures is included in the Investors section of our website. I will now turn the call over to Mary Ann.

speaker
Mary Ann Haino
CEO and Executive Chairperson

Thank you, Mark, and good morning, everyone. We had a strong start to the year with solid performance across Polarify, Neuroseek, and DFINITY. These results reflect our ongoing commitment to focus and discipline across the organization. As we said last quarter, 2026 is a year of commercial execution and regulatory milestones. We're making deliberate choices about where we focus our commercial effort and deploying capital so we're positioned to deliver solid results in 2026, and accelerate growth in 2027. Our corporate focus is centered on radio diagnostics, and our priorities for 2026 are clear. First, maintain our market leadership in PSMA PET while preparing for a seamless transition to polarify TrueView, our newly approved PSMA PET formulation, beginning in the fourth quarter. Second, continue to build momentum for Neuroseq through deeper penetration within existing accounts, Leveraging the breadth of the Lanthea's portfolio to unlock incremental growth opportunities and expanding our manufacturing footprint, increasing supply availability. Third, advance our late stage clinical portfolio through key regulatory milestones and ensure launch readiness aligned with coding, coverage, payment, customer preparedness, and market opportunity. And finally, allocate capital with discipline. prioritizing radio diagnostics while evaluating value-maximizing alternatives for our radiotherapeutic assets. In addition to effective commercial execution, we advance several key programs during the quarter that support our long-term growth strategy. On March 6th, the FDA approved Polarify TrueView, our new PSMA PET imaging agent. Polarify TrueView offers the same proven diagnostic properties as Polarify with a similar safety and efficacy profile. The value add of this product will be the larger batch sizes that can be enabled at manufacturing sites with high energy cyclotrons. This creates the potential to serve more patients and support a broader geographic reach. We estimate that more than 70% of Polarify's supply today is produced at PMF sites equipped with high-energy cyclotrons, giving us confidence that, through our broad PMF network, we are well-positioned to optimize the benefit that Polarify TrueView can provide. We also announced during the quarter the FDA extended the PDUFA date for Octavi by three months to June 29, 2026, to allow additional time to review manufacturing-related information. Similar to our efforts with Polarify TrueView, we remain focused on advancing launch readiness, including securing coding, coverage, payment, and customer preparedness through the second half of 2026, with the objective of a full commercial launch in early 2027. On March 2nd, we announced that the FDA had offered tentative approval for PNT-2003, the first radio equivalent to Lutathera. for the treatment of gastroenteropancreatic neuroendocrine tumors, or GPNETs. Tentative approval confirms that the FDA has completed its substantive review and that our application meets the requirements for approval. The timing of our launch will consider the following factors. Timing of final FDA approval, the expiration of the 30-month Hatch-Waxman stay, and disposition of the related legal proceedings, as well as manufacturing and commercial strategy to ensure launch success. As outlined last quarter, our strategy and related investments are centered on radio diagnostics, and the progress we made this quarter reflects that focus. We are selectively prioritizing first and best-in-class pet radio diagnostic assets that complement our existing commercial portfolio and align closely with our nuclear medicine customer base. I will highlight a few key pipeline updates. MK6240, our registrational stage TAU-targeted pet radio diagnostic for Alzheimer's disease, represents an important asset within our pharma solutions portfolio and is the leading imaging agent supporting late-stage Alzheimer's disease-modifying therapy, or DMT, developments. It is currently the most widely used imaging agent in beta amyloid and tau-targeted therapeutic candidate clinical programs. MK6240 serves as an imaging agent for treatment eligibility in 17 current pharma-sponsored AD therapeutic programs and has a PDUFA date of August 13th of this year. Lantheus 2401, our gastrin-releasing peptide receptor, or GRPR, targeted PET radio diagnostic for prostate cancer, is advancing towards its planned registrational program this year. GRPR is a differentiated target from PSMA, and Lantheus 2401 has the potential to complement PSMA PET imaging by identifying disease in patients who may be PSMA negative or equivocal. extending the addressable prostate cancer population while fitting naturally within our existing prostate cancer franchise. Across the pipeline, we remain disciplined in strategically deploying investments based on stage gates and long-term opportunity. With robust mid and long-term revenue drivers, a promising late-stage pipeline, and a clear strategic roadmap, we are confident in our ability to drive meaningful performance gains that support a compelling outlook for our shareholders. and we're executing against that plan. Our strong first quarter results reinforce that 2026 will be a year of commercial execution and regulatory progress, laying the groundwork for growth acceleration beginning in 2027. I also want to provide a brief update on our CEO search. The board's process is progressing well, and we have narrowed the search to a small number of highly qualified candidates. In the meantime, our leadership team and I remain fully focused on execution as the first quarter results fully demonstrate. I will now hand the call over to Amanda to provide additional detail on commercial performance across our oncology, neurology, and cardiology assets.

Disclaimer

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Investor presentation